AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-

Q: Who is the manufacturer of AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-?

Seppim S.A.S. filed the 510(k) submission for AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- (K093883).

Q: What is the FDA product code for AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-?

CIT. It is classified under 21 CFR 862.1100 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-?

ABX PENTRA CP AST Reagent (k060318); Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501); Roche Diagnostics Precinorm U and Precipath U (k041227).

Q: Who can help prepare an FDA 510(k) submission like AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K093883 · Seppim S.A.S. · CIT · Sep 20, 2010 · Clinical Chemistry

Device Facts

Record ID	K093883
Device Name	AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
Applicant	Seppim S.A.S.
Product Code	CIT · Clinical Chemistry
Decision Date	Sep 20, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1100
Device Class	Class 2

Intended Use

The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use. ELITech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate aminotransferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart disease. ELITech Clinical Systems Elical 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL I is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzers.

Device Story

The AST/GOT 4+1 SL is an in vitro diagnostic reagent kit used on the Vital Scientific Selectra/Flexor Junior benchtop discrete photometric chemistry analyzer. The system measures AST activity in human serum or plasma samples using a modified IFCC method (without pyridoxal-phosphate). The reagent consists of two parts: R1 (Tris buffer, L-Aspartate, MDH, LDH) and R2 (alpha-Ketoglutarate, NADH). The analyzer performs photometric measurements to determine enzyme activity, which is then used by clinicians to diagnose and monitor liver and heart conditions. The system requires calibration using ELICAL 2 and quality control using ELITROL I and II. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Performance evaluation included precision (within-run and total CVs), method comparison against the predicate (y=1.016x - 1.86, R^2=0.9998), and stability studies (refrigerated on-board stability of 28 days). No clinical prospective or retrospective studies were required.

Technological Characteristics

Reagent kit: R1 (Tris buffer, L-Aspartate, MDH, LDH, sodium azide) and R2 (alpha-Ketoglutarate, NADH, sodium azide). Photometric chemistry analyzer (discrete, benchtop). Liquid, ready-to-use reagents. Storage at 2-8°C. Calibration via ELICAL 2 (lyophilized human serum). Quality control via ELITROL I/II (lyophilized human serum).

Indications for Use

Indicated for the quantitative determination of Aspartate amino transferase (AST) in human serum and plasma to aid in the diagnosis and treatment of liver and heart diseases.

Regulatory Classification

Identification

An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

ABX PENTRA CP AST Reagent (k060318)
Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501)
Roche Diagnostics Precinorm U and Precipath U (k041227)

Related Devices

K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL · Thermofisher Scientific OY · Oct 3, 2007
K980902 — N-ASSAY L AST/GOT · Crestat Diagnostics, Inc. · Mar 26, 1998
K980030 — AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) · Trace America, Inc. · Jan 30, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ - SEP 20 2010 ### SECTION 5 - 510(k) Summary - ELITech Clinical Systems AST/GOT 4+1 SL on Vital Scientific Selectra Junior #### According to the requirements of 21 CFR 807.92, the following Introduction information provides sufficient detail to understand the basis for a determination of substantial equivalence. The assigned 510(k) number is : K093883 | Submitter | SEPPIM S.A.S. | |---------------------|-----------------------------------------------------| | Address | Zone Industrielle, 61500 SEES, FRANCE | | Phone number | + 33 (0)2 33 81 21 00 | | Fax number | + 33 (0)2 33 28 77 51 | | Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | | Date of Preparation | November 27th, 2009 | #### Device names | REAGENT : | | | ELITech Clinical Systems Device (AST/GOT 4+1 SL) | Predicate device (ABX PENTRA AST CP) | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade/proprietary Name: | ELITech Clinical Systems AST/GOT 4+1 SL | Intended use | ELITech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. analyzers for the quantitative in vitro diagnostic determination of the enzyme Aspartate amino transferase (AST) in human serum and plasma. | For in vitro diagnostic use in the quantitative determination of aspartate aminotransferase (AST) in serum or plasma. | | Common or Usual Name: | AST-Aspartate amino Transferase, "AST/GOT 4+1 SL" | Indication for Use | Measurement of aspartate amino transferase levels aids in the treatment of certain types of liver and heart diseases. | Measurement of aspartate amino transferase levels aids in the treatment of certain types of liver and heart disease. | | Device Class | Class II | Assay protocol | Modified IFCC method without pyridoxal -phosphate | Optimized UV test according to IFCC modified method without pyridoxal phosphate. | | Classification name | Aspartate amino transferase (AST/SGOT) Test system (21 CFR.862.1100) | Composition | Reagent R1: TRIS pH 7.8, 100 mmol/L; L- Aspartate 330 mmol/L; MDH ≥ 1000 U/L; LDH ≥ 2000 U/L; Sodium azide < 1g/L Reagent R2: $\alpha$ -Ketoglutarate 78 mmol/L; NADH 1.1 mmol/L; Sodium azide < 1g/L | Reagent R1: TRIS pH 7.8 110 mmol/L; L- Aspartate 340 mmol/L; MDH ≥ 900 U/L; LDH ≥ 900 U/L; Sodium azide < 1g/L Reagent R2: 2-oxoglutarate 85 mmol/L; NADH 1.09 mmol/L; Sodium azide < 1g/L | | Product code | CIT; NADH oxidation/NAD reduction, Ast/Sgot | Appearance of reagents | Liquid form, ready to use | Liquid form, ready to use | | INSTRUMENT: | | Traceability/Standardization | IFCC formulation (Schumann, 2002), manual measurement | IFCC Reference Measurement Procedure (37°C) for ASAT | | Trade/Proprietary Name: | Vital Scientific Selectra Junior | Sample type | Serum Plasma in lithium heparin | Serum Plasma in lithium heparin | | Common or Usual Name: | Clinical analyzer, "Selectra Junior" | Reagent storage | Store at 2-8°C and protected from light. The reagents are stable until the expiry date stated on the label | Reagents, in unopened cassette are stable up to expiry date or the label if stored at 2-8°C, and contamination is avoided. | | Device Class: | Class I | Expected values | Serum, Plasma (37°C) :< 40 U/L | Women < 31 U/L Men < 35 U/L 37°C | | Classification Name: | Discrete Photometric Chemistry Analyzer for Clinical Use (21 CFR 862.2160) | Instrument | Vital Scientific Selectra Junior Analyzer (also trademarked as the Flexor Junior Analyzer) | ABX PENTRA 400 | | Product Code: | JJE | Measuring range | 10 to 250 U/L | 3.70 U/L to 600 U/L | | Predicate devices | ABX PENTRA AST CP (K060318) Vitalab Flexor (973628) | | | | | Device description | The reagent device for this submission is available as kit only. It consists of 2 reagents: Reagent 1 contains Tris buffer, L-Aspartate; Lactate dehydrogenase (LDH) (microorganisms), Malate dehydrogenase (MDH) (bacterial) and sodium azide. Reagent 2 contains α-Ketoglutarate, NADH and sodium azide The Vital Scientific Selectra Junior is a benchtop discrete chemistry photometric analyzer for in vitro diagnostic use. | | | | #### Intended Use The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital The Vital Scientific Octooria Vanioi Andiyaret photometric chemistry analyzer for in vitro diagnostic use. {1}------------------------------------------------ ELITech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart disease. ELITech Clinical Systems AST/GOT 4+1 SL is intended to measure the Indication(s) for Use enzyme Aspartate amino transferase (AST) in human serum and plasma. Measurements of aspartate amino transferase levels are used in the treatment of certain types of liver and heart diseases. Comparison to Predicate device {2}------------------------------------------------ ### SEPPIM S.A.S. Zone industrielle 61500 SEES France | | | Automatic post-dilution:1800 U/L | |-----------------------|-----------------------------|----------------------------------| | Precision | Within run | Within run | | | Level 21.2 U/L CV=2.3% | Level 42 U/L CV=2.7% | | | Level 46.4 U/L CV=0.8% | Level 123 U/L CV=1.4% | | | Level 203.4 U/LCV=0.5% | Level 22 U/L CV=2.3% | | | Total | Level 38 U/L CV=2.0% | | | Level 21.2 U/L CV=3.8% | Level 145 U/L CV=1.1% | | | Level 46.4 U/L CV=1.2% | Total | | | Level 203.4 U/LCV=2.7% | Level 42 U/L CV=3.1% | | | | Level 126 U/L CV=2.5% | | | | Level 43 U/L CV=3.6% | | | | Level 348 U/L CV=5.0% | | Method comparison | $y=1.016x - 1.86$ U/L | $y=0.99x +1.01$ U/L | | | $R^2= 0.9998$ | $r^2= 0.9966$ | | | range: 9.5 to 234.4 U/L | range: 3.70 to 671.80 U/L | | Calibration Frequency | 28 days | 8 days | | On board stability | refrigerated area : 28 days | refrigerated area: 55 days | #### Conclusion The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not and choolivenood of this containce criteria, demonstrating that the Compromised, and that it met all accopianos and addition and the substantially {3}------------------------------------------------ ### SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELICAL 2 c | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The assigned 510(k) number is: K093883 | | Submitter | SEPPIM S.A.S. | | Address | Zone Industrielle, 61500 SEES, FRANCE | | Phone number | + 33 (0)2 33 81 21 00 | | Fax number | + 33 (0)2 33 28 77 51 | | Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | | Date of Preparation | November 27th, 2009 | | Device names REAGENT | | | Trade/proprietary Name: | ELITech Clinical Systems ELICAL 2 | | Common or Usual Name: | Calibrator, secondary, "ELICAL 2" | | Device Class | Class II | | Classification name | Calibrator (21 CFR 862.1150) | | Product code | JIT- Calibrator, secondary | | Predicate device | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) | | | (K033501) | | Device description | ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A. | | Intended Use | ELITech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. | . . {4}------------------------------------------------ #### Comparison to Predicate device | | ELITech Clinical Systems Device (ELICAL-2) | Predicate device (Roche Calibrator f.a.s.) | |--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | ELITech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. | For in vitro diagnostic use in the calibration of quantitative Roche methods on Roche clinical chemistry analysers as specified in the value sheets. | | Format | Lyophilized calibrator based on human serum with constituents added as required to obtain desired components levels | Lyophilized calibrator based on human serum with constituents added as required to obtain desired components levels | | Level | Single level | Single level | | Handling | Carefully open the vial, avoiding the loss of lyophilate, and pipette in exactly 3 mL of distilled/deionized water. Carefully close the vial and dissolve the contents completely by occasional gentle swirling within 30 minutes avoiding the formation of foam. | Carefully open one bottle, avoiding the loss of lyophilate, and pipette in exactly 3 mL of distilled/deionized water. Carefully close the bottle and dissolve the contents completely by occasional gentle swirling within 30 minutes. Avoid the formation of foam. | | Traceability | Traceability information is given in the value sheet included in the box. | Traceability of the target value is given in the respective instruction for use of the system reagents. | | Stability | Lyophilized: To store at 2-8°C and protected from light until the expiry date After reconstitution, the stabilities are: - 8 hours between 15-25 °C. - 2 days between 2-8 °C. - 4 weeks between -25 and -15 °C (when frozen once) | Lyophilized: Stable at 2-8°C up to expiration date. After reconstitution, the stabilities* are : - 8 hours at 15-25 °C. - 2 days at 2-8 °C. - 4 weeks at (-25)-(-15) °C (when frozen once) *Exception for bilirubin total & direct as noted in package insert | #### Conclusion The performance data and other information demonstrate that the safety The performance data and other the prodicate device is not i he performance uata and other information redicate device is not and effectiveness of this device versus the predicate demonstrating and effectiveness of this device versus the prodicate do need to that the local that the local that the line the compromised, and that it met all acceptants only as nonel and and : \ {5}------------------------------------------------ #### SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELITROL I and ELITROL II and the control of the control of the control of the contribution of the country of the country of the county of the country of the country of the country of the country of t | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | |----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The assigned 510(k) number is: K093883 | | Submitter Address Phone number Fax number | SEPPIM S.A.S. Zone Industrielle, 61500 SEES, FRANCE + 33 (0)2 33 81 21 00 + 33 (0)2 33 28 77 51 | | Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | | Date of Preparation | November 27th, 2009 | | Device names | | | CONTROLS: Trade/proprietary Name: Common or Usual Name: Device Class Classification name Product code | ELITech Clinical Systems ELITROL I and ELITROL II Single analyte, Assayed, "ELITROL I"- "ELITROL II" Class I Quality control material (assayed and unassayed). (21 CFR 862.1660) JJX- Single (specified) analyte control, (assayed) | | Predicate device | Roche Diagnostics Precinorm U (K041227) Roche Diagnostics Precipath U (K041227) | | Device description | ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A. | | Intended Use | ELITech Clinical Systems ELITROL I is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical | " . . . {6}------------------------------------------------ Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers. . : : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ﺮ ﻣ . . . . . ්‍යය 127 ක් ක්‍රීඩා - {7}------------------------------------------------ Public Health Service #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white. Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993 SEP 2 0 2010 Seppim S.A.S. c/o Debra Hutson ELITech Group Epoch Biosciences 21720 2314 Dr. SE, Suite 150 Bothell, Washington 98021 Re: k093883 > Trade Name: AST/GOT 4+1 SL Regulation Number: 21 CFR §862.1100 Regulation Name: Aspartate aminotransferase (AST/SGOT) Test System Regulatory Class: Class II Product Codes: CIT, JJX, JIT, and JJE Dated: August 30, 2010 Received: September 1, 2010 . . Dear Ms. Hutson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations (1 Nr.), It may be bacyed to Title 21, Code of Federal Regulations (CFR), Parts attroching your addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does r lease be aur 1960 that 1271 b isdetermination that your device complies with other not mean that I Dr. has or any Federal statutes and regulations administered by other requirements of the Pro. of al. on al. the Act's requirements, including, but not r ederal agencies: "Fouring (21 CFR Part 807); labeling (21 CFR Parts 801 and minted to: registration and the porting of medical device-related adverse events) (21 607), medical do res reporting (top practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {8}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, CJC. Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ K093883 SEP 2 0 2010 ## Indications for Use Form 510(k) Number (if known): _K093883 Device Name: Vital Scientific Selectra Junior Analyzer (also trademarked as the Flexor Junior Analyzer) AST/GOT 4+1 SL_ Indications for Use: The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use. ELITech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign Off Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K093883 {10}------------------------------------------------ # Indications for Use Form 12093883 SEP 2 0 2010 510(k) Number (if known): _K093883 Device Name: Indications for Use: ELITech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign Off Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 1093883 510(k)________________________________________________________________________________________________________________________________________________________________________ {11}------------------------------------------------ ### Indications for Use Form 510(k) Number (if known): K093883 ELITROL I and ELITROL II_ ____________________________________________________________________________________________________________________________________________________ Device Name: Indications for Use: ELITech Clinical Systems ELITROL I is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers. X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) WA Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 12093883 16093883

AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-

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AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-

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